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Europe Clinical Trials Regulation

Problems With Drug Absorption Studies Still ‘Relatively Common’ In EU

Inadequacies Have Drawn Major Objections During Initial EMA Review

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Executive Summary

A retrospective analysis of new drugs evaluated by the European Medicines Agency since 2010 shows that a lack of, or major deficiencies in, human mass balance studies is still a concern in regulatory submissions.

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Europe Clinical Trials Regulation
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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